NCT05302258

Brief Summary

For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 18, 2022

Last Update Submit

March 29, 2022

Conditions

Hepatic SteatosisObesity, ChildhoodUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of attenuation imaging

    The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis

    through study completion, an average of 1 year

Study Arms (2)

Obesity

BMI of 95 th percentile or more

Diagnostic Test: Attenuation imaging in ultrasonography

Normal weight

BMI of 85 th percentile or less

Diagnostic Test: Attenuation imaging in ultrasonography

Interventions

Attenuation imaging in ultrasonographyDIAGNOSTIC_TEST

Attenuation imaging in ultrasonography

Normal weightObesity

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Obese and normal-weight children

You may qualify if:

  • BMI of 85th percentile or less

You may not qualify if:

  • congenital anomaly including heart, intestine, kidney
  • acute hepatitis
  • congenital hepatic anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatty LiverPediatric Obesity

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 31, 2022

Study Start

April 14, 2022

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03